CORRECTION: Independent Laboratory Test Results Confirm Value of DermaPreciseTM Injection Consistency in Clinical Simulation Testing
CORRECTION: Independent Laboratory Test Results Confirm Value of DermaPreciseTM Injection Consistency in Clinical Simulation Testing
This press release replaces the press release disseminated July 26, 2022 at 06:00 EDT. The press release contained the wrong image - one intended for a future press release. The corrected press release with the proper image is below:
本新聞稿取代了美國東部時間2022年7月26日06:00發佈的新聞稿。新聞稿中包含了錯誤的圖片--一張本打算在未來的新聞稿中使用的圖片。更正後的新聞稿和正確的圖片如下:
VANCOUVER, BC / ACCESSWIRE / July 26, 2022 / RepliCel Life Sciences Inc. (OTC PINK:REPCF) (TSXV:RP) (FRA:P6P2) ("RepliCel" or the "Company"), a company developing next-generation technologies in aesthetics and orthopedics, announced today it has now received and analyzed all data and images from independent laboratory testing of the DermaPreciseTM injector prototype and consumables evaluating the injection systems' various depths and doses in donated human skin tissue*.
温哥華,卑詩省/ACCESSWIRE/2022年7月26日/RepliCel生命科學公司(場外交易代碼:REPCF)(多倫多證券交易所股票代碼:RP)(法蘭克福證券交易所股票代碼:P6P2)(以下簡稱RepliCel或公司)今天宣佈,它已經收到並分析了DermaPrecise獨立實驗室測試的所有數據和圖像TM在捐贈的人體皮膚組織中評估注射系統的不同深度和劑量的注射器原型和消耗品*。
Monasterium Laboratory, a German-based laboratory specializing in dermatology research, tested intradermal and subcutaneous injections of different volumes to provide evidence of whether or not DermaPrecise was capable of delivering controlled and consistent injections as observed, recorded, and measured in donated, human skin tissue.
Monasterium實驗室是一家總部設在德國的專門從事皮膚病研究的實驗室,該公司測試了不同劑量的皮內和皮下注射,以提供證據,證明DermaPrecise是否能夠像在捐贈的人體皮膚組織中觀察、記錄和測量的那樣,提供受控和一致的注射。
Human full thickness skin biopsies were injected with marker ink with viscosity matching commonly used drugs. Post-injection, the skin was cut into sections to be stained and evaluated. The injection parameters for depth and volume showed test results meet or surpass DermaPrecise objectives for consistency of volume and depth delivery. Sample pictures accompanying this press release show the kind of imagery captured in data accumulation pertaining to the injections.
在人體全層皮膚活檢組織中注入與粘度匹配的常用藥物的標記墨水。注射後,將皮膚切成切片進行染色和評估。深度和體積的注射參數表明,測試結果達到或超過了DermaPrecise關於體積和深度輸送一致性的目標。本新聞稿附帶的樣本圖片顯示了在與注射有關的數據積累中捕獲的圖像類型。
"Analysis of the tests performed, confirms the unique injection consistency of the DermaPrecise™ injection system within a specified range in the tissue. With manual injections using a standard needle and syringe there is no guaranteed consistency in terms of injection depth or volume, but with the DermaPrecise™ there is uniform injection which allows for a large area of skin to be injected with the same amount of active substance in every single injection," stated Kevin McElwee, RepliCel's Chief Science Officer.
RepliCel首席科學官凱文·麥克爾韋説:“對測試結果的分析證實了™注射系統在組織內特定範圍內的獨特注射一致性。使用標準針頭和注射器的手動注射不能保證注射深度或體積的一致性,但對於DemaPrecise™,注射是均勻的,允許在每一次注射中向大片皮膚注射相同數量的活性物質。”
"What we are starting to see with these tests on donated human skin is evidence that the system is performing in accordance with the design, engineered functionality and intended uses of the DermaPreciseTM system," stated R. Lee Buckler, President and CEO of RepliCel Life Sciences, which developed and owns all rights to the DermaPreciseTM product portfolio and its underlying technologies. "It is intended to deliver a high level of control and consistent precision for intra-dermal and subcutaneous injections," he continued.
通過對捐贈的人體皮膚進行的這些測試,我們開始看到的是該系統正在按照DermaPrecise的設計、工程功能和預期用途運行的證據TMRepliCel生命科學公司的首席執行官R·李·巴克勒説,該公司開發並擁有DermaPrecise的所有權利TM產品組合及其底層技術。“它的目的是為皮內和皮下注射提供高水平的控制和一致的精確度,”他繼續説。
"As we continue to prepare for commercial launch of the DermaPreciseTM product line, it is critical we have these kinds of independent validation of the injection parameters and our ability to deliver best-in-class precision to our end users. Testing with donated human skin samples is a valuable tool in convincing clinicians to evaluate new technologies in real clinical treatment settings."
隨着我們繼續為DermaPrecise的商業推出做準備TM在我們的產品線中,至關重要的是我們擁有對注塑參數的這種獨立驗證,以及我們向終端用户提供同類最佳精度的能力。用捐贈的人體皮膚樣本進行測試是説服臨牀醫生在真實的臨牀治療環境中評估新技術的寶貴工具。“
Dermatologist and clinical researcher Dr. Rolf Hoffmann, who has been a clinical advisor for the DermaPrecise™ development, stated: "As clinicians learn more about the mechanisms and effects of the various types of substances we inject into the dermis and subcutaneous tissue - including neurotoxins, fillers, antibody therapeutics, fat-dissolving enzymes, cell therapies, and other injectables - they are increasingly realizing that precision of depth, dose and/or delivery matters more to efficacy than was often originally believed."
皮膚科醫生和臨牀研究員羅爾夫·霍夫曼博士一直是DermaPrecise™開發的臨牀顧問,他説:“隨着臨牀醫生對我們注入真皮和皮下組織的各種物質的機制和效果有了更多的瞭解--包括神經毒素、填充物、抗體療法、脂溶酶、細胞療法和其他注射劑--他們越來越意識到深度、劑量和/或傳遞的精確度對療效的影響比人們最初認為的更重要。”
About Monasterium Laboratory GmbH
關於Monasterium實驗室有限公司
Monasterium Laboratory GmbH, located in Münster Germany, is a fast-growing, dermatological research company specialized in preclinical skin, hair, pigmentation, neuroendocrinology, immunology, and wound healing research in the human system.
Monasterium實驗室有限公司位於德國明斯特,是一家快速發展的皮膚科研究公司,專門從事臨牀前皮膚、頭髮、色素沉着、神經內分泌學、免疫學和人體系統傷口癒合研究。
* Note: All experiments on human tissue are performed according to Helsinki guidelines and samples are collected after patient consent and ethics approval under relevant jurisdiction laws.
*注:所有人體組織實驗都是根據赫爾辛基指南進行的,樣本是在患者同意和相關司法管轄區法律下的道德批准後收集的。
About the DermaPreciseTM Injector Product Line
關於DermaPreciseTM噴油器產品線
The DermaPreciseTM Injector platform is an electronic injection system which will bring new levels of control over intra-dermal or subcutaneous injections where precision of depth, dose and/or delivery consistency matters.
真皮精品TM注射器平臺是一種電子注射系統,它將把對皮內或皮下注射的控制提升到新的水平,在這些地方,深度、劑量和/或輸送一致性的精確度至關重要。
About RepliCel Life Sciences
關於RepliCel生命科學
RepliCel is a regenerative medicine company focused on developing cell therapies for aesthetic and orthopedic conditions affecting what the Company believes is approximately one in three people in industrialized nations, including aging/sun-damaged skin, pattern baldness, and chronic tendon degeneration. These conditions, often associated with aging, are caused by a deficit of healthy cells required for normal tissue healing and function. These cell therapy product candidates are based on RepliCel's innovative technology, utilizing cell populations isolated from a patient's healthy hair follicles.
RepliCel是一家再生醫學公司,專注於為美學和整形外科疾病開發細胞療法,該公司認為,在工業化國家中,大約三分之一的人會受到影響,包括老化/陽光損傷的皮膚、花紋禿頂和慢性肌腱退化。這些情況通常與衰老有關,是由正常組織癒合和功能所需的健康細胞不足引起的。這些候選細胞治療產品基於RepliCel的創新技術,利用從患者健康毛囊中分離出來的細胞羣。
The Company's cell therapy product pipeline is comprised of RCT-01 for tendon repair, RCS-01 for skin rejuvenation, and RCH-01 for hair restoration. RCH-01 has been the subject of successful safety and dose-finding clinical studies and is now the subject of its third clinical study evaluating efficacy for the treatment of male and female hair loss due to androgenetic alopecia. This ongoing study is being funded by Shiseido Company Limited pursuant to a license agreement which has now been terminated, but is the subject of an arbitration regarding Shiseido's rights to the product for Asia. RepliCel maintains the undisputed rights to RCH-01 for the rest of the world. RCT-01 and RCS-01 are exclusively licensed in Greater China to YOFOTO (China) Health Company. RepliCel and YOFOTO are currently co-developing these products in China. RepliCel maintains the rights to these products outside of Greater China.
該公司的細胞療法產品線包括用於肌腱修復的RCT-01、用於皮膚再生的RCS-01和用於頭髮修復的RCH-01。RCH-01一直是成功的安全性和劑量發現臨牀研究的對象,現在是其第三項臨牀研究的對象,評估治療雄激素性脱髮引起的男性和女性脱髮的療效。這項正在進行的研究由資生堂有限公司根據一項許可協議提供資金,該協議現已終止,但該協議是關於資生堂在亞洲對該產品的權利的仲裁的對象。RepliCel為世界其他地區保留了RCH-01無可爭議的權利。RCT-01和RCS-01在大中華區獨家授權給YOFOTO(中國)健康公司。RepliCel和YOFOTO目前正在中國共同開發這些產品。RepliCel保留了這些產品在大中華區以外的權利。
RepliCel has also developed a proprietary injection device (DermaPreciseTM) and related consumables, which is expected to improve the administration of its cell therapy products and certain other injectables. YOFOTO has exclusively licensed the commercial rights for the DermaPrecise™ device and consumables in Greater China for dermatology applications and is expected to first launch the product in Hong Kong upon it being approved for market launch in either the United States or Europe. Please visit replicel.com for additional information.
RepliCel還開發了一種專有的注射設備(DermaPreciseTM)和相關消耗品,預計將改善其細胞治療產品和某些其他注射劑的管理。YOFOTO已獨家授權DermaPrecise™設備和耗材在大中華區用於皮膚科應用的商業權利,並預計在獲準在美國或歐洲上市後,首先在香港推出該產品。有關更多信息,請訪問Replicel.com。
Notable Facts:
值得注意的事實:
- RepliCel's three cell therapy products have now been tested in over 100 patients in four countries on three continents.
- RepliCel now has key strategic regional partners each of which are now investing heavily in the further clinical testing and development of RepliCel's products for their markets. Data from each of the clinical programs will strengthen the product development initiatives for RepliCel and its other partners worldwide.
- RepliCel的三種細胞治療產品現在已經在三大洲四個國家的100多名患者中進行了測試。
- RepliCel現在擁有關鍵的戰略地區合作伙伴,每個合作伙伴現在都在為其市場進一步投資RepliCel產品的進一步臨牀測試和開發。來自每個臨牀項目的數據將加強RepliCel及其全球其他合作伙伴的產品開發計劃。
For more information, please contact:
Lee Buckler, CEO and President
604-248-8693
info@replicel.com
如需更多信息,請聯繫:
李巴克勒,首席執行官兼總裁
604-248-8693
郵箱:Info@Replicel.com
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
多倫多證券交易所風險交易所及其監管服務提供商(該術語在多倫多證券交易所的政策中定義)均不對本新聞稿的充分性或準確性承擔責任。
SOURCE: RepliCel Life Sciences, Inc.
資料來源:RepliCel生命科學公司
譯文內容由第三人軟體翻譯。